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NCT Number: NCT07573059

Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients

Arginase 1 deficiency (ARG1-D) is a rare condition in which the body cannot properly break down a substance called arginine. This leads to high levels of arginine and related substances in the blood, which can cause serious health problems and reduce quality of life.

Loargys is a new treatment designed to lower arginine levels in people with ARG1-D. It works by providing a modified version of a natural enzyme that breaks down arginine in the blood. The dose of Loargys is adjusted for each patient based on their arginine levels.

Because Loargys continues to break down arginine even after a blood sample has been taken, to ensure accurate results, a special substance (called nor-NOHA) is added to the blood collection tubes to stop this process after the sample is taken. The arginine levels are then measured using a standard laboratory test.

The Loargys Arginine Test System used in this study includes both the special blood collection tubes and the laboratory test used to measure arginine.

The purpose of this study is to evaluate the safety of this test system when used to measure arginine levels in patients receiving Loargys.

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Key information

Conditions

ARG1 Deficiency Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hyperargininemia Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Urea Cycle Disorders, Inborn

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rare Disease Research

Atlanta, Georgia, 303029, United States

Location status: Recruiting

Location contact

CLEAR Study Coordinator

CONTACT

[email protected]

678-883-6897

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant receiving treatment with commercialized Loargys for ARG1-D
  • Participant is willing to sign the Informed Consent Form

Exclusion criteria

  • None

Treatment and study plan

Loargys Arginine Test System

Device

Loargys Arginine Test System

Primary outcomes

  1. Incidence of AEs related to the Loargys Arginine Test System

    Time frame: Through study completion, up to 21 months

Study contacts

Contact information is provided by the study sponsor or research team.

Head of Global Integrated Evidence Generation

CONTACT

[email protected]

+46(0)853339500

Sponsors and collaborators

Lead sponsor

Immedica Pharma US Inc

Industry

Registry information

Official study title

A Multicenter, Prospective Study Assessing the Safety of Loargys Arginine Test System for Determining Arginine in Loargys-treated Patients

Acronym: CLEAR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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